BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LAP-BAND AP ADJUSTABLE GASTRIC BANDING SYSTEM (LARGE)

    MDR report key: 1994361 · Received January 14, 2011

    Report

    Report Number
    2024601-2011-00041
    Event Type
    Malfunction
    Date Received
    January 14, 2011
    Date of Event
    September 15, 2010
    Report Date
    September 15, 2010
    Manufacturer
    ALLERGAN
    Product Code
    LTI
    PMA / PMN Number
    P000008
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    TAPER II. MEDWATCH SENT TO FDA ON: (B)(4) 2011. THE REPORTER OF THE EVENT WAS ASKED TO RETURN THE PRODUCT FOR ANALYSIS. THE REPORTER SAID THE PRODUCT ASSOCIATED WITH THIS REPORT HAS BEEN DISCARDED. BASED UPON THE SERIAL NUMBER AND IMPLANT DATE PROVIDED BY THE REPORTER THE CONNECTOR TYPE IS ASSUMED TO BE A TAPER II. DEVICE LABELING ADDRESSES THE POSSIBLE OUTCOME OF LEAKAGE AS FOLLOWS: "DEFLATION OF THE BAND MAY OCCUR DUE TO LEAKAGE FROM THE BAND, THE PORT OR THE CONNECTOR TUBING."

    Description of Event or Problem · 1

    COMPANY REP REPORTED ON BEHALF OF THE HEALTH PROFESSIONAL A LAP-BAND WAS EXPLANTED FOR AN UNK REASON. F/U INFO RECEIVED FROM THE HEALTH PROFESSIONAL NOTED IT WAS EXPLANTED DUE TO A "FAILED LAP BAND." THE SURGEON WROTE, "THE EXPLANTED LAP BAND HAD A LINEAR CRACK/TEAR ALONG THE BALLOON. THE TEAR WAS NOT CIRCULAR, BUT PERPENDICULAR. THERE WAS A TEAR IN THE BAND, NOT A NEEDLE PUNCTURE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LAP-BAND AP ADJUSTABLE GASTRIC BANDING SYSTEM (LARGE) LTI ALLERGAN NA 1737193

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR